Bipolar DisorderPhase 3NCT00067262
An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents
A Phase 3 study testing Divalproex Sodium Extended-Release Tablets in people with Bipolar Disorder, run by Abbott at 16 sites in United States.
Trial summary
The purpose of this study is to determine the safety and effectiveness of Depakote ER (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and adolescents ages 10-17 years. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Divalproex Sodium Extended-Release Tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- 16 sitesUnited States
- Study dates
- Mar 2003to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Current primary diagnosis of bipolar I disorder, mania or mixed type
- Outpatient between 10 and 17 years of age
- Young Mania Rating Scale score greater than or equal to 20 during screening/washout and at Day 1
Who cannot join
- Axis I other than Attention Deficit Hyperactivity Disorder (ADHD), Obsessive Compulsive Disorder (OCD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Panic Disorder; or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results
- Current manic episode is drug-induced or secondary to a medical disorder (e.g., anti-depressants, hyperthyroidism)
- Expected to require hospitalization for the current manic episode
- Participation in psychotherapy that was started within the past 3 months, or if any significant changes are anticipated
- Has taken atomoxetine or has taken allowed stimulant medication that has not been stable for at least 3 months prior to Day 1, or a dosage adjustment is expected during the study, or that may worsen mood symptoms
- Unable to swallow tablets
Show all 12Show fewer
- Has received depot psychoactive medication within one inter-injection interval of Day 1
- Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine, barbiturates, benzodiazepines or amphetamines
- History of alcohol or substance dependence within past 3 mos. or substance abuse within past month
- History of failed treatment on adequate Depakote (DR or ER) for a manic episode within past 12 months
- Has taken Depakote (DR or ER) regularly for the current manic episode
- Has serious violent, homicidal, or suicidal ideation
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Study site
Altamonte Springs, Florida, 32701
Mountain West Clinical Trials
Boise, Idaho, 83704
Mercy Health Research
Chesterfield, Missouri, 63017
New Oakland Child/Adoles and Family Center
Clinton Township, Michigan
University of Texas Medical Branch
Galveston, Texas, 77705
University of Texas Medical Branch
Houston, Texas, 77058
Study site
Lexington, Kentucky, 40509
Capstone Clinical Research
Libertyville, Illinois, 60031
Professional Clinical Research, Inc.
Miami, Florida, 33161
LSU - Health Science Center
New Orleans, Louisiana, 70112
Cientifica Inc at Praire View, Inc.
Newton, Kansas, 67114
Segal Institute for Clinical Research
North Miami, Florida, 33161
Cutting Edge Research Group
Oklahoma City, Oklahoma
Brentwood Research Institute
Shreveport, Louisiana, 71101
Stanford University
Stanford, California, 94304
Childrens National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: A Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Depakote ER for the Treatment of Bipolar Disorder in Children and Adolescents
The purpose of this study is to determine the safety and effectiveness of Depakote ER (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and adolescents ages 10-17 years.
- Conditions
- Bipolar Disorder
- Being tested
- Divalproex Sodium Extended-Release Tablets
- Keywords
- Bipolar Disorder Type 1 (manic or mixed type)
- Medical subject headings
- Bipolar Disorder, Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Divalproex Sodium Extended-Release TabletsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to the final evaluation in Y-MRS score.
Secondary outcomes (2)
Vital signs
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2003 (estimated)
- Study startMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Medical Information, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067262
- Sponsor's protocol ID
- M01-342
- Status last verified
- Aug 2006
- First submitted
- 13 Aug 2003
- Last updated
- 4 Aug 2006
- Results posted
- No
Publications
Wagner KD, Redden L, Kowatch RA, Wilens TE, Segal S, Chang K, Wozniak P, Vigna NV, Abi-Saab W, Saltarelli M. A double-blind, randomized, placebo-controlled trial of divalproex extended-release in the treatment of bipolar disorder in children and adolescents. J Am Acad Child Adolesc Psychiatry. 2009 May;48(5):519-532. doi: 10.1097/CHI.0b013e31819c55ec.
PubMed 19325497
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Depakote ER for the Treatment of Bipolar Disorder in Children and Adolescents
- ClinicalTrials.gov ID
- NCT00067262
- Acronym / sponsor ID
- M01-342
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder Type 1 (manic or mixed type)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- First posted
- 15 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and effectiveness of Depakote ER (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and adolescents ages 10-17 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Current primary diagnosis of bipolar I disorder, mania or mixed type
- Outpatient between 10 and 17 years of age
- Young Mania Rating Scale score greater than or equal to 20 during screening/washout and at Day 1
Key exclusion criteria (12 listed)
- Axis I other than Attention Deficit Hyperactivity Disorder (ADHD), Obsessive Compulsive Disorder (OCD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Panic Disorder; or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results
- Current manic episode is drug-induced or secondary to a medical disorder (e.g., anti-depressants, hyperthyroidism)
- Expected to require hospitalization for the current manic episode
- Participation in psychotherapy that was started within the past 3 months, or if any significant changes are anticipated
- Has taken atomoxetine or has taken allowed stimulant medication that has not been stable for at least 3 months prior to Day 1, or a dosage adjustment is expected during the study, or that may worsen mood symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Divalproex Sodium Extended-Release Tablets | Drug | – |
Primary outcome
Change from baseline to the final evaluation in Y-MRS score.
2 secondary outcomes
Vital signs
Adverse events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2006.
- Derived from this study: PubMed 19325497Wagner KD, Redden L, Kowatch RA, Wilens TE, Segal S, Chang K, Wozniak P, Vigna NV, Abi-Saab W, Saltarelli M. A double-blind, randomized, placebo-controlled trial of divalproex extended-release in the treatment of bipolar disorder in children and adolescents. J Am Acad Child Adolesc Psychiatry. 2009 May;48(5):519-532. doi: 10.1097/CHI.0b013e31819c55ec.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Medical Information study director
Abbott
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Divalproex Sodium Extended-Release Tablets in people with Bipolar Disorder, run by Abbott at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to the final evaluation in Y-MRS score.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00067262, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2006.